The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Mv Darkroom Cassette.
Device ID | K931074 |
510k Number | K931074 |
Device Name: | DU PONT MV DARKROOM CASSETTE |
Classification | Cassette, Radiographic Film |
Applicant | E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Contact | Richard M Forbis |
Correspondent | Richard M Forbis E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington, DE 19880 |
Product Code | IXA |
CFR Regulation Number | 892.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-02 |
Decision Date | 1993-06-08 |